Etoposide 100mg/5ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Etoposide

Available from:

Actavis UK Ltd

ATC code:

L01CB01

INN (International Name):

Etoposide

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010400; GTIN: 5012617025401 5012617025418

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ETOPOSIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Etoposide
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.

If you get side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Etoposide Injection is and what it is used for.
2. What you need to know before you use Etoposide Injection.
3. How to use Etoposide Injection.
4. Possible side effects.
5. How to store Etoposide Injection.
6. Contents of the pack and other information.
1. WHAT ETOPOSIDE INJECTION IS AND WHAT IT IS USED FOR
This medicine contains the active substance etoposide. It works by
interfering production cycle of DNA and slow or
stop the growth of cancer cells.
Etoposide Injection is used in combination with other anti-cancer
medicines to treat:

small-cell lung cancer.

acute
monoblastic
&
acute myelomonoblastic
leukaemia (cancer of the blood-forming tissues of bone
marrow).

testicular tumours (cancer of testis).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETOPOSIDE INJECTION
DO NOT USE ETOPOSIDE INJECTION

if you are allergic to etoposide,
podophyllotoxines or podophyllotoxine-derivatives or any other
ingredients of
this medicine (listed in section 6).

if your liver is not working properly.

if your bone marrow does not produce enough blood cells.

if you are breast-feeding.

if you have a weak immune system and you are being vaccinated against
yellow fever at the same time.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before you use Etoposide
Injection:

if you have a low serum alb

Summary of Product characteristics

OBJECT 1
ETOPOSIDE 20MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 01-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
Etoposide 20mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
1 ml of concentrate for solution for infusion contains 20 mg of
etoposide.
One vial of 5 ml concentrate for solution for infusion contains 100 mg
of etoposide.
Excipients with known effect:
1 ml of concentrate for solution for infusion contains 158 mg ethanol.
One vial of 5 ml concentrate for solution for infusion contains 790 mg
ethanol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear, pale yellow solution, slightly viscous, free from visible
particles
The pH is between 3,0 and 4,0
The osmoloarity is > 2000 mOsmol/L.
4. Clinical particulars
4.1 Therapeutic indications
TESTICULAR CANCER
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of
first line, recurrent or refractory testicular cancer in adults.
SMALL CELL LUNG CANCER
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of
small-cell lung cancer in adults.
HODGKIN'S LYMPHOMA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of
Hodgkin's lymphoma in adult and paediatric patients.
NON-HODGKIN'S LYMPHOMA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of
non-Hodgkin's lymphoma in adult and paediatric patients.
ACUTE MYELOID LEUKAEMIA
Etoposide is indicated in combination with other approved
chemotherapeutic agents for the treatment of
acute myeloid leukaemia in adult and paediatric patients.
GESTATIONAL TROPHOBLASTIC NEOPLASIA
Etoposide is indicated for first line and second line therapy in
combination with other approved
chemotherapeutic agents for the treatment of high risk gestational
trophoblastic neoplasia in adults.
OVARIAN C